Nature-based Sensory Stimulation on Pain Levels

Fibromyalgia Clinical Trial

Official title:

The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017220
• Other study ID #: NBS in chronic pain patients
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

Description:

All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
• Chronic widespread musculoskeletal pain symptoms (>1 location using the Widespread Pain Index).
• High-intensity pain (VAS = 4), at least 3 days a week for the previous 3 months.
• If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
• Over 18 and less than 65 years old (labour active).
• Ability to speak and understand English or Spanish.

Exclusion Criteria:

• Acute or temporal pain
• Severe cognitive impairment, detected by the Mini-Mental State Examination (score <24 out of 30 points)
• Severe mental disorders in acute phase or symptomatic phase
• Behavioural alterations as this may interfere in their participation
• Severe intellectual disability
• Other severe or medically unstable diseases interfering with the project participation
• Co-occurrence of neuropathic pain
• Other disorders that may cause pain
• Pregnant or breast-feeding
• Drug abuse within the past year.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Nature-based sensory stimuli
A program based on stimulation using nature-based sensory stimuli will be implemented
• Control group intervention
An activity based on a placebo intervention will be implemented

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10	Change from baseline pain intensity after 30 minutes
Primary	Cold pain thresholds	Cold pressor test will be used	Change from baseline cold pain thresholds after 30 minutes
Primary	Punctate mechanical hyperalgesia	Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used	Change from baseline mechanical hyperalgesia after 30 minutes
Primary	Wind-up phenomenon	Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception.	Change from baseline temporal summation of pain perception after 30 minutes
Primary	Pressure pain thresholds	The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold	Change from baseline pressure pain thresholds after 30 minutes